Axsome Therapeutics Inc (AXSM)

[georgejjl]

Axsome (AXSM) Surges on Potential Approval for AXS-05 Soon

Axsome Therapeutics, Inc. AXSM announced that it has received post-marketing requirements/commitments proposed by the FDA related to its new drug application (“NDA”) seeking approval for one of its lead candidates, AXS-05. The company has also agreed to the FDA’s proposal.

The NDA is seeking approval for AXS-05 as a potential treatment for major depressive disorder (“MDD”). Following this new regulatory update related to the AXS-05 NDA, the company believes that the FDA may provide a decision during the second quarter.

Axsome’s shares gained 25.1% on Apr 19, following the receipt of proposed post-marketing requirements/commitments from the FDA. In fact, shares of Axsome have gained 8.3% so far this year against the industry’s decline of 15.6%.

Axsome filed the NDA for AXS-05 in 2021, which was granted priority review by the FDA. A decision was previously expected in August 2021. However, the FDA extended the review period for the NDA in August last year, citing deficiencies within the NDA that preclude labeling discussions, including deficiencies related to analytical methods in the chemistry, manufacturing, and controls section of the NDA. The regulatory authority informed the company that it will not be able to take action related to the NDA until the deficiencies are addressed.

On its fourth-quarter earnings call, Axsome stated that it has already submitted a response to these deficiencies, which have been duly received by the FDA. AXSM stated that the responses filed by it are not major amendments to the NDA.

Investors cheered the recent update from the FDA amid uncertainty related to the review timeline for the AXS-05 NDA for MDD. A potential approval will lead to the first commercialized product for Axsome.

The company has been actively engaged in preparing for the commercial launch of AXS-05 targeting MDD patients in the past few months regardless of the extension of the review timeline for its NDA.

Apart from MDD, Axsome is also developing AXS-05 for treating treatment-resistant depression (“TRD”), smoking cessation and agitation associated with Alzheimer's disease (“AD”). The company is currently enrolling patients in the phase III ACCORD study, which is evaluating the safety and efficacy of AXS-05 for treating agitation associated with AD. It plans to start a pivotal phase II/III study for AXS-05 as a potential treatment for smoking cessation. The timing of the initiation will be informed later this year.

In a bid to strengthen its portfolio, Axsome signed an agreement with Jazz Pharmaceuticals JAZZ last month to acquire the latter’s new sleep drug, Sunosi.

Jazz has received approval for Sunosi as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea. Jazz currently commercializes Sunosi in the United States, Europe and several other countries.

https://finance.yahoo.com/news/axsome-axsm-surges-potential-approval-144902498.html

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